Acute Myocardial Infarction
Conditions
Brief summary
To determine the therapeutic effects of Tongxinluo Capsules as compared with placebo in the treatment of patients with acute ST-elevation myocardial infarction (STEMI): (1) Clinical efficacy and safety at 30 days: the incidence of composite endpoints comprising major adverse cardiovascular and cerebrovascular events (MACCE, including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), severe complications (including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias), and major bleeding (BARC grade III and V); (2) Clinical efficacy and safety at 1 year: the incidence of composite endpoints comprising MACCE, hospitalization due to heart failure, in-stent thrombosis, and major bleeding (BARC grade III and V), as well as all-cause mortality; (3) the effects in promoting myocardial reperfusion, reducing incidence of myocardial no-reflow, protecting ischemic myocardium, minimizing infarction size, and improving left ventricular systolic function.
Interventions
DRUGTongxinluo
tid, po.
DRUGPlacebos
tid, po.
Sponsors
China National Center for Cardiovascular Diseases
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age\>18 years; 2. Within 24 hours of infarctional chest pain onset; 3. ECG shows ST-segment elevation ≥0.2mV in more than 2 adjacent leads, or new left bundle branch block (LBBB); 4. Voluntary participation in the study with consent forms signed.
Exclusion criteria
1. Critically illness due to STEMI; 2. Long-term (\>20 min) cardio-pulmonary resuscitation (CPR); 3. Suspected aortic dissection or acute pulmonary embolism; 4. Explicit mechanical complications, including interventricular septum perforation, rupture of papillary muscles and chordae tendineae, or on-going or ruptured left ventricular free walls. 5. Serious cardiogenic shock and do not responding to hypertensive agents; 6. Uncontrolled acute left heart failure or pulmonary edema; 7. Malignant arrhythmias uncontrolled by anti-arrhythmia agents; 8. Bleeding history of cerebral vessels, gastrointestinal tract, respiratory tract, urinary tract or other organs within 1 month; 9. Presence of active hemorrhage at any part of the body (including menstruation); 10. Known hemorrhagic constitution or serious hemostasis and blood coagulation disorders; 11. Current usage of anticoagulants (such as Warfarin or new anticoagulants); 12. . Serious hepatorenal dysfunction \[ATL≥5 ULN (upper limit of normal), Cr\>134μmol/L (2mg%) or eGFR\<45ml/min/1.73m2\]; 13. Serious chronic obstructive pulmonary disease (COPD) or respiratory failure; 14. . Severe infection: 15. . Very weak or frailty; 16. . Neuropsychiatric system diseases; 17. . Malignancies; 18. . Other pathophysiological conditions with expected survival time \<1 year; 19. Allergy to the ingredients of this investigational drug; 20. Women who are in pregnancy or nursery; 21. Participation in clinical study of other traditional Chinese medicine (TCM); 22. Unsuitability to participate in this study due to other diseases.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MACCE | 30-day | 30-day incidence of composite endpoint events comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| STEMI | 30-day | 30-day incidence of severe complications of STEMI including cardiogenic shock, heart failure, mechanical complications and malignant arrhythmias. |
| MACCE | 1 year | 1-year incidence of composite endpoints comprising MACCE (including cardiovascular death, myocardial re-infarction, emergency coronary revascularization and cerebral stroke), re-hospitalization due to heart failure, in-stent thrombosis and major bleeding (BARC grade III and V), and the incidence of each primary endpoint event. |
| In-stent restenosis | 1 year | 1-year incidence of In-stent restenosis |
| All-cause mortality rate at 1 year | 1 year | Symptoms improved after treatment. Evaluate all-cause mortality rate at 1 year. |
| Myocardial reperfusion and no-reflow | 2 hours, 24 hours and 7 days | Evaluation of Myocardial reperfusion and no-reflow: resolution of elevated ST-segment in ECG and incidence of no-reflow at 2h, 24h and 7 days after reperfusion therapy. |
| Revascularization | 30-day | Incidence of revascularization of the primary endpoints |
| Cerebral stroke | 30-day | Incidence of cerebral stroke of the primary endpoints |
| The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V | 30-day | The incidence of bleeding in BARC（Bleeding Academic Research Committee Bleeding Standard） III and V at 30-day between 0-30%. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin | 7 days, 1 month, 6 months and 1 year after medication | Normal value: 110-150, unit: g/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range. |
| Blood platelet count | 7 days, 1 month, 6 months and 1 year after medication | Normal value: 100-300, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range. |
| Total white cell count | 7 days, 1 month, 6 months and 1 year after medication | Normal value: 4-10, unit: 109/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range. |
| Red blood cell | 7 days, 1 month, 6 months and 1 year after medication | Normal value: 3.5-5, unit: 1012/L.Check at 7 days, 1 month, 6 months and 1 year to see if it is within the normal range. |
Countries
China
Contacts
Primary ContactXiang-Dong Li, MD
Outcome results
None listed